ID

40317

Description

A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01970059

Link

https://clinicaltrials.gov/show/NCT01970059

Keywords

Versions (1)
  1. 4/7/20 4/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01970059

English

Eligibility Hypertension NCT01970059

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
aged from 18 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
had a history of essential hypertension
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
average sitting diastolic blood pressure≧90mmhg，but≦109mmhg
Description

Sitting diastolic blood pressure Average

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C1510992
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
malignant hypertension
Description

Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020540
average sitting systolic blood pressure≧180mmhg
Description

Sitting diastolic blood pressure Average

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C1510992
type 2 diabetes with hemoglobin a1c≥9%
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
new york heart association class ⅱ-ⅳ congestive heart-failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
unstable angina
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
Description

Second degree atrioventricular block | Complete atrioventricular block | History of sick sinus syndrome | Exception Pacemaker Present

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3]
C3494553
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0810633
UMLS CUI [4,3]
C0150312
atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
bradycardia (<60 bpm, seated)
Description

Bradycardia | Beats per minute Sitting position

Data type

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2,1]
C0439385
UMLS CUI [2,2]
C0277814
asthma or other obstructive pulmonary disease
Description

Asthma | Lung Diseases, Obstructive

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0600260
history of myocardial infarction
Description

History of myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1275835
stroke in the 6 months before screening
Description

Cerebrovascular accident Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332185
known contraindications to β-adrenergic blocker therapy
Description

Medical contraindication Adrenergic beta-Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001645
glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase＞3 times upper limit of normal
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
crea＞2 times upper limit of normal
Description

Creatinine increased

Data type

boolean

Alias
UMLS CUI [1]
C0151578
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hypertension NCT01970059

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
males or females
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged from 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
had a history of essential hypertension
boolean
C0085580 (UMLS CUI [1])
Sitting diastolic blood pressure Average
Item
average sitting diastolic blood pressure≧90mmhg，but≦109mmhg
boolean
C1319894 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Sitting diastolic blood pressure Average
Item
average sitting systolic blood pressure≧180mmhg
boolean
C1319894 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
type 2 diabetes with hemoglobin a1c≥9%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class ⅱ-ⅳ congestive heart-failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block | History of sick sinus syndrome | Exception Pacemaker Present
Item
second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C3494553 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0810633 (UMLS CUI [4,2])
C0150312 (UMLS CUI [4,3])
Atrial Fibrillation
Item
atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Bradycardia | Beats per minute Sitting position
Item
bradycardia (<60 bpm, seated)
boolean
C0428977 (UMLS CUI [1])
C0439385 (UMLS CUI [2,1])
C0277814 (UMLS CUI [2,2])
Asthma | Lung Diseases, Obstructive
Item
asthma or other obstructive pulmonary disease
boolean
C0004096 (UMLS CUI [1])
C0600260 (UMLS CUI [2])
History of myocardial infarction
Item
history of myocardial infarction
boolean
C1275835 (UMLS CUI [1])
Cerebrovascular accident Recent
Item
stroke in the 6 months before screening
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Medical contraindication Adrenergic beta-Antagonists
Item
known contraindications to β-adrenergic blocker therapy
boolean
C1301624 (UMLS CUI [1,1])
C0001645 (UMLS CUI [1,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase＞3 times upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine increased
Item
crea＞2 times upper limit of normal
boolean
C0151578 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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